The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets.
Following the ANDA approval, the company has also annonunced the immediate launch of the tablets.
Rizatriptan benzoate, which are avilable in both 5mg and 10mg versions, are being manufactured and supplied by Natco Pharma.
The tablets are AB rated to Maxalt, a prescription medicine to treat migraines. Maxalt, marketed by Merck, has a $320m drug market, according to Breckenridge.
Established in 1983, Breckenridge is a private pharmaceutical marketing, research and development company that markets number of generic prescription products and medical foods for wide therapeutic categories.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/us-fda-grants-anda-for-breckenridges-rizatriptan-benzoate-tablets-311212
